If an amphetamine is approved for binge-eating, will it be used off-label for weight loss?

In addition to a flurry of new weight-loss drugs, the U.S. Food and Drug Administration recently authorized the use of an ADHD drug to treat binge-eating disorder -- a diagnosis that is rejected by some medical professionals.

But critics worry that the DSM-5 approval will prompt doctors and patients to start using the drug, Vyvanse, for weight-loss instead.

Allen Frances, MD, a former chair of the psychiatry department at Duke University, called binge-eating disorder "a makeshift diagnosis with very little research support that will now undoubtedly become a fad pushed by massive pharma advertising."

"It is no different from the diet pills that don't work for obesity, that do create a secondary illegal market, and that reap vast profits at patient expense," Frances said.

Frances was the chairman of the panels that produced the DSM-4. Binge-eating disorder was not recognized as a disorder in that edition.

In the DSM-5 published in 2013, the condition was included, in part to increase awareness of the difference between it and common overeating. An estimated 2.8 million people in the U.S. are said to have the condition.

The FDA approved the new use for Vyvanse, manufactured by Shire Pharmaceuticals, under its priority review program, which provides for an expedited review of drugs that are intended to treat serious conditions and that may offer a significant improvement in treatment.

According to the FDA, Vyvanse was given a priority review -- which typically is completed in 6 months instead of the standard 10 -- because binge-eating disorder had no other treatment.

In approving the drug, the FDA relied on data from two 12-week clinical trials that tested Vyvanse against a placebo in patients who had, on average, nearly five binge-eating sessions per week. In those trials, the drug reduced the binge-eating days by 3.9 per week.

But the placebo also seemed effective, reducing the binge eating days by 2.5 and 2.3 per week in each trial, respectively.

Frances called the two studies "small, very inadequate, short-term treatment trials," and said the FDA "should, in my opinion, require a year of follow."

The agency has refused to provide the documents it used in reviewing the drug.

The Milwaukee Journal Sentinel and MedPage Today requested the documents in a Feb. 3 email, and reiterated the request March 5. On March 9, the news organizations made a formal request for the documents under the Freedom of Information Act.

The request "won't come up in the queue to review for approximately 24 months," FDA spokesman Eric Pahon wrote in an email.

Last July, the Journal Sentinel requested information on fees paid by drug companies to the FDA in order to have their new drug applications reviewed. That request still is pending.

When asked about the prospect of Vyvanse being used off-label, Pahon said the FDA does not regulate the practice of medicine, but noted the drug is not approved for treating obesity.

First approved in 2007 to treat ADHD, Vyvanse is an amphetamine that can cause increase blood pressure and heart rate. The FDA says its most serious risks include psychiatric and heart complications, including sudden death in people with heart ailments and also the risk of stroke and heart attack in adults.

The drug carries the agency's most stringent "black box" warning for its potential to be abused.

A Milwaukee Journal Sentinel/MedPage Today analysis of the FDA's adverse events reporting system, which is one measure of problems associated with a drug, showed the Vyvanse was a "primary suspect" in at least 70 deaths and 400 hospitalizations reported since 2007.

Shire, which manufactures Vyvanse, spent $5.3 million lobbying Congress and the FDA since 2010, a Journal Sentinel/MedPage Today review found.

The company also made $1.9 million in payments to doctors for speaking, travel, and food during the last 5 months of 2013 alone -- the only period for which disclosures have been made public on the federal Open Payments site. Of that, $426,000 was specific to Vyvanse.

Last year, Shire paid $56 million to settle a U.S. Justice Department allegation that it illegally promoted several of its drugs, including Vyvanse. Federal officials had accused Shire of making unsupported claims that treatment with Vyvanse would prevent car accidents, divorce, arrests, and unemployment.

In an email, Shire spokeswoman Gwen Fisher said the company has never lobbied or made any requests of Congress regarding the use of Vyvanse in adults to treat binge-eating disorder.

"In terms of Shire's interactions with physicians, we collaborate with the medical and scientific community for a broad range of activities, from conducting clinical trials to providing insight about patient care needs," she wrote. "Through our interactions, we receive valuable information that can help us better serve healthcare professionals and patients."

She said there was an unmet medical need for adults with binge-eating disorder, adding: "Shire is always careful to point out that medication is not appropriate for all adults with (the condition)."

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